Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion

NCT ID: NCT06402656

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-01-01

Brief Summary

The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed.

This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.

Each patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.

Conditions

Malocclusion, Angle Class III; Extraoral Traction Appliances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Customized facemask

Group Type: EXPERIMENTAL

Customized facemask

Intervention Type: DEVICE

The customized face mask will be fabricated from a 3D digital image of the patient's face obtained by means of a 3D scanner. Such a scanner consists of 6 digital SLR cameras and software capable of processing a 3-D image of the patient's face exportable as an stl file.

Standard facemask

Group Type: ACTIVE_COMPARATOR

Standard facemask

Intervention Type: DEVICE

The standard facemask is the commercially available Petit standard facemask

Interventions

Customized facemask

The customized face mask will be fabricated from a 3D digital image of the patient's face obtained by means of a 3D scanner. Such a scanner consists of 6 digital SLR cameras and software capable of processing a 3-D image of the patient's face exportable as an stl file.

Intervention Type: DEVICE

Standard facemask

The standard facemask is the commercially available Petit standard facemask

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 5 and 12 years;
• Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.
• signing of informed consent

Exclusion Criteria

• Cleft lip and/or palate.
• Craniofacial syndromes.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LF14

Identifier Type: -

Identifier Source: org_study_id